MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREEDOM LITE METER FREESTYLE; BLOOD GLUCOSE MONITORING SYSTEM

Model Number	70914-70
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer's product has been retuned for investigation.A follow-up report will be submitted once all investigation activities are complete.All pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
A customer reported receiving erroneous glucose results from an abbott diabetes care device.The results when plotted on a parkes error grid fell into the c zone.The length of sensor wear was days.There was no report of death, serious injury, or mistreatment associated with this event.
Event or Problem Description
Customer reported receiving a low reading from their abbott diabetes care device.Customer reported a low reading of 47 mg/dl which was lower than a adc meter in reading of 333 mg/dl.The results when plotted on a parkes error grid fell into the "d" zone showing the difference in values to be clinically significant.There was no report of death, serious injury, or mistreatment associated with this event.
Additional Manufacturer Narrative
The returned meter was investigated with retained test strips.Visual inspection was performed on returned meter.No issues were observed.Meter powered on with button depression and test strip insertion.Control solution testing has been performed and all results were within range spec2954323-2024-39394-1ification.Therefore, this issue is not confirmed.An extended investigation has been performed for the reported complaint and it has been determined that there was no indication that the product did not meet specification.At this time the freestyle strip has not been returned.The dhrs (device history review) for the freestyle freedom lite meter was reviewed and the dhrs (device history review) showed the freestyle freedom lite meter passed all tests prior to release.Dhrs (device history review) for the freestyle strips was reviewed and the dhrs showed the freestyle strips passed all tests prior to release.Retain testing was performed for freestyle strip, and all units performed in specification and passed.If the strip is returned, a physical investigation will be performed per adc's established processes and procedures and a report will be submitted upon completion of investigation.All pertinent information available to abbott diabetes care has been submitted.

• Brand Name: FREEDOM LITE METER FREESTYLE
• Common Device Name: BLOOD GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE INC; 1360 south loop road; alameda 94502 7001
• Manufacturer Contact: audra fuentes ; 1360 south loop road; alameda 94502-7001 ; 5107495297
• MDR Report Key: 20370370
• Report Number: 2954323-2024-39394
• Device Sequence Number: 3689221
• Product Code: NBW
• UDI-Device Identifier: 00699073714992
• UDI-Public: (01)00699073714992(10)04C193D(17)240331
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K092602
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/31/2026
• Device Model Number: 70914-70
• Device Lot Number: 1203604
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2024
• Supplement Date Received by Manufacturer: 12/20/2024
• Initial Report FDA Received Date: 10/04/2024
• Supplement Report FDA Received Date: 12/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 68 KG
• Patient Ethnicity: Hispanic
• Patient Race: White